Kornimate/medical-research-clean huggingface dataset:
comparison between reciproc and protaper next

Conditions: Dental Pulp Necrosis

Summary: comparing the postoperative pain resulting after mechanical instrumentation using reciproc reciprocating files versus that resulting after using protaper next rotary files in asymptomatic necrotic molars.

asymptomatic necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using reciproc files or protaper next files. postoperative pain is then assessed using the numerical rating scale 6, 12, 24 and 48 hours post-instrumentation. the tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the numerical rating scale after 12 and 24 hours following obturation. the time required to complete instrumentation is also measured and compared using the two files.

Eligibility criteria:
inclusion criteria: * mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis exclusion criteria: * patients on medication for chronic pain * patients with pre-operative pain. * patients having significant systemic disorders. * patients with two or more adjacent teeth requiring root canal therapy * teeth that have vital pulp tissues, greater than grade i mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.
effect of a home-based versus supervised exercise program in patients with migraine

Conditions: Migraine; Exercises

Summary: migraine is a common primary headache with documented impacts on the patient, the economy, and society. a growing number of studies have reported that people with migraines are more likely to experience neck pain and neck dysfunction. the coexistence of migraine and neck pain is also associated with a higher frequency of migraine attacks, greater susceptibility to certification. it has been reported that they present decreased cervical mobility, as well as decreased strength, resistance, and coordination of the cervical musculature of the skull. the objective of this study is to evaluate the possible clinical effects in migraineurs of supervised craniocervical and axioscapular exercises versus home-based exercises.

this study will aim to verify the effect of home versus supervised exercise programs in migraine patients. the primary outcomes will be changes in the visual analog scale (vas) (0-10) and migraine disability assessment scores (midas). secondary outcomes will be changes in cervical range of motion; change in muscle endurance test; neck disability index (ndi), headache impact test (hit-6) score, patient health questionnaire (phq-9) scores, generalized anxiety disorder (gad-7) scores. volunteers for the study will be included if they are between 18 and 55 years old, are of either sex, have been diagnosed with migraine according to the third edition of the international classification of headache, and have exhibited at least 3 days with migraine attacks in the previous month, then will be randomly assigned into two groups. a single therapist will administer the interventions twice a week for 8 weeks. the experimental group (supervised) will carry out a supervised exercises program twice a week in comparison with the control group (no supervised) and will carry out a home-based exercise program twice a week. these volunteers will be recruited at the university of gran rosario, (rosario, argentina). primary and secondary outcomes will be measured at both groups' baseline and the end of the treatment. all the evaluations will be performed by a blinded physiotherapist

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of migraine according to the beta version of the third edition of the international classification of headache disorders (ichd), with or without pharmacological treatment. * age ranging between 18 to 55 years, both genders exclusion criteria: * patients with neurological disorders (neuropathic pain or neurodegenerative disease), * whiplash associated disorders, * specific neck pain (radicular pain), * recent dental or physical therapy. * if patients are taking medication to relieve pain during the study, they will be encouraged to report it.

Keywords: craniocervical flexion exercises neck exercises axioscapular exercises
mandibular reconstruction preplanning (vipmr)

Conditions: Oral Cavity Cancer; Oral Cancer

Summary: virtual surgical planning (vsp), where 3d modeling is used to create 3d-printed surgical guides, has been shown to improve outcomes for patients who undergo mandibular reconstruction surgery, usually due to invasion of cancer from the oral cavity to the jaw. this trial will directly compare the outcomes of patients who receive vsp versus patients who receive the current standard of care, which is free-hand surgery (fhs). they will be randomized into either treatment at a 1:1 ratio and bony union rates will be compared between 12-month postoperative ct scans for each treatment group. secondary objectives include comparing other short and long-term complication rates, reconstruction accuracy, quality of life, and functional outcomes of vsp and fhs. an economic analysis of vsp will also be performed.


Eligibility criteria:
inclusion criteria: * primary diagnosis requiring mandibulectomy and fibular or scapular free flap reconstructive surgery * are over the age of 18 * cognitive ability and language skills that allow participation in the trial * provide informed consent exclusion criteria: * severe comorbidities including metastatic disease * do not have a recent (within 30 days) ct scan and are unable/unwilling to receive a head ct scan at the latest 6 days prior to surgery * prior history of head or neck cancer within last 5 years * prior history of head or neck radiation treatment at any time * pregnant of lactating women

Keywords: oral cavity cancer oral cancer mandibular reconstruction
an innovative image-based method for extensibility assessment

Conditions: Hypertrophic Scar

Summary: this study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.

1. quasi-experimental, single-group pre-post intervention: participants will receive a standardized physical therapy protocol targeting scar contracture. after intervention, scar extensibility will be measured using traditional tools (vancouver scar scale, tonometer) and a newly developed image-based method. 2. methodological validation approach: the image-based method will be tested for: * reliability (test-retest, inter-rater) * validity (concurrent validity against established tools and construct validity)

Eligibility criteria:
inclusion criteria: * history of clinically diagnosed scar contracture following thermal burns. * presence of scars (≥6 months post-burn) to ensure stability for accurate assessment. * scars located on functionally mobile areas (e.g., limbs) where extensibility impacts daily activities. * willingness to undergo a standardized physical therapy intervention. * ability to provide informed consent and comply with all study procedures. exclusion criteria: * active infection, unhealed wounds, or unstable scars at the assessment site. * diagnosed systemic diseases affecting collagen synthesis or wound healing (e.g., scleroderma, uncontrolled diabetes). * history of experimental or non-standard scar treatment within the last 3 months. * severe cognitive impairments or communication barriers that interfere with understanding or participation. * pregnant or lactating women, due to hormonal influences on tissue healing and collagen metabolism. * concurrent participation in other physical therapy or rehabilitation studies targeting scar management.

Keywords: image-based assessment scar extensibility assessment.
diaphragmatic function and respiratory drive in osa and copd

Conditions: Obstructive Sleep Apnea

Summary: this cross-sectional observational study aims to assess the diaphragmatic morphofunction and respiratory drive characteristics among patients with obstructive sleep apnea (osa), chronic obstructive pulmonary disease (copd), overlap syndrome (os), and healthy controls. using ultrasound imaging and surface diaphragm electromyography (emgdi), the study will explore group differences in diaphragmatic morphology, function, and respiratory drive indicators, and evaluate their clinical significance in disease differentiation and severity assessment.

this is a single-center cross-sectional study designed to compare the diaphragmatic morphofunction and respiratory drive among four groups: osa, copd, overlap syndrome (patients with both osa and copd), and healthy controls. participants will undergo overnight polysomnography (psg), spirometry, impulse oscillometry, and diaphragm ultrasound combined with surface emgdi measurements. the study will analyze group differences in diaphragmatic thickness, excursion, thickening fraction, and emgdi parameters including emgdi-rest, emgdi-max, and emgdi%max. the relationships between diaphragmatic indicators and respiratory parameters (fev1, fvc, ahi, r5-r20, etc.) will also be assessed. this study aims to provide objective evidence for diaphragmatic dysfunction characterization in osa and copd, as well as to explore its diagnostic utility in overlap syndrome.

Eligibility criteria:
inclusion criteria: 1. patients aged between 18 and 80 years. 2. for osa group: diagnosed obstructive sleep apnea with ahi ≥ 5 events/hour based on overnight polysomnography. 3. for copd group: diagnosed chronic obstructive pulmonary disease based on gold guidelines. 4. for overlap group: diagnosed both osa (ahi ≥ 5) and copd. 5. for control group: healthy volunteers with no known respiratory diseases or sleep disorders. 6. ability and willingness to provide informed consent for participation in the study. exclusion criteria: 1. severe cardiovascular diseases (e.g., unstable angina, heart failure nyha iii/iv). 2. severe hepatic or renal insufficiency. 3. neuromuscular diseases affecting respiratory muscles. 4. recent upper airway or thoracic surgery (within 3 months). 5. pregnancy or breastfeeding. 6. participants who cannot complete assessments due to cognitive impairment or poor cooperation.

Keywords: obstructive sleep apnea chronic obstructive pulmonary disease overlap syndrome
global symplicity registry (gsr) define

Conditions: Hypertension

Summary: this is a prospective, multi-center, single-arm, non-interventional and open-label registry. the purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension gsr define is the continuation of the global symplicity registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. subjects included in gsr define will be followed for a minimum of 1 year and up to 5 years post-procedure. patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.

this registry will collect data prospectively on patients that receive renal denervation and treatment will be applied according to the 'intended use' in the ifu. the treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. this registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the medtronic renal denervation system in a real world patient population. the key measures collected for the patients will be inclusive of, but are not limited to, blood pressure measurements, change in medications, egfr changes (based on the mdrd formula) and clinical data pertaining to hypertension . the inclusion criteria for the registry includes: * age ≥ 18 years or minimum age as required by local regulations * the patient is an acceptable candidate for renal denervation based upon the instructions for use for the medtronic renal denervation system. the procedure must be performed with an initial use, market-released medtronic renal denervation catheter. * the patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("patient informed consent form" or "patient data release authorization form")

Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations * the patient is an acceptable candidate for renal denervation based upon the instructions for use for the medtronic renal denervation system. the procedure must be performed with an initial use, market-released medtronic renal denervation catheter. * the patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("patient informed consent form" or "patient data release authorization form")
safety and efficacy of kpi-121 in subjects with ded

Conditions: Kerato Conjunctivitis Sicca

Summary: the primary purpose of this study is to determine the efficacy and safety of kpi-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. the product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (qid).

this is a phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of kpi-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Eligibility criteria:
inclusion criteria: * have a documented clinical diagnosis of dry eye disease in both eyes exclusion criteria: * known hypersensitivity or contraindication to the investigational product(s) or components * history of glaucoma, iop\>21 mmhg at the screening or randomization visits, or being treated for glaucoma in either eye. * diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening. * in the opinion of the investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
trial of a brief psychological intervention for suicidal patients with borderline personality disorder in the emergency department

Conditions: Borderline Personality Disorder; Suicide and Self-harm

Summary: when in crisis, people with borderline personality disorder (bpd) frequently seek care in emergency departments (eds) often presenting with suicide and self-harm behaviour. there is no established evidence-based brief intervention for patients with bpd in ed settings, however a 4-session psychotherapeutic intervention for people with personality disorders in ed settings was tested in australia and showed promising results in reduced health care utilization. the proposed pilot randomized controlled trial will assess the feasibility of delivering this 4-session intervention in the ed for people with bpd who present with suicidal ideation or self-harm with the aim of reducing health care utilization.


Eligibility criteria:
inclusion criteria: 1. aged 16 or older 2. presenting to ed with self-harm and/or suicidal ideation; and 3. meeting criteria for bpd on the structured clinical interview for dsm-5 personality disorders exclusion criteria: 1. unable to give informed consent; 2. meeting dsm-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder i mania based on the structured clinical interview for dsm-5 (28); and/or 3. iq \< 70 based on the wechsler test of adult reading
a study of the association between tobacco smoking and bipolar affective disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)

an association exists between smoking and schizophrenia, independent of other factors and related to psychotic symptomatology. only a few small descriptive studies have examined the prevalence and correlates of tobacco use among bipolar patients with conflicting results. patients who smoke score higher on rating scales for psychotic symptoms than their non-smoking peers. while the association of smoking with psychotic symptomatology in schizophrenia is established, such association according to bipolar affective disorder has been reported in a few studies and remains unclear. also a few studies reported about association of smoking with depressive and manic symptoms, and with suicidal behavior in bipolar patients. thus further investigation of these issues is warranted.

Eligibility criteria:
inclusion criteria: * age 18-65 male or female * dsm -iv criteria for bipolar i affective disorder * ability and willingness to sign informed consent for participation in the study exclusion criteria: * unwillingness or inability to participate in the study

Keywords: bipolar affective disorder, smoking
longitudinal study of weight change following lower limb amputation

Conditions: Amputation Wound; Traumatic Amputation of Toe; Dysvascular Amputation of Lower Limb

Summary: the purpose of this study is to assess weight change in a population of veterans with amputations. little is known about the how weight changes following an amputation. it is widely believed that many patients experience weight gain following amputation. this study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.


Eligibility criteria:
inclusion criteria: "exposed" cohort: * incident lower limb amputation during the study period (1/1997-12/2008) in visn 20 * \>= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation) * \>=1 weight measured post amputation (2 months to 42 months post amputation) "unexposed" (comparison) cohort: * no lower limb amputation during the study period * no prior history of amputation * \>= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline"). * alive at least 18 months after "baseline" exclusion criteria: * female (due to small number of women with lower limb amputations) * lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)
gastric cancer complicated with bleeding

Conditions: Gastric Cancer

Summary: to investigate the impact of bleeding on the survival and treatment-related adverse events (traes) of gastric cancer patients.

we will retrospectively enroll patients diagnosed with advanced or metastatic gastric cancer at the department of medical oncology and radiation sickness of peking university third hospital. the retrospective study aims to investigate the impact of bleeding on treatment-related adverse events (traes) for gastric cancer patients receiving systematic anticancer treatment, assess the influence of bleeding on the survival of patients.

Eligibility criteria:
inclusion criteria: 1. patients older than 18 years; 2. a histologically confirmed diagnosis of advanced or metastatic gastric cancer; 3. the initial anticancer treatment was systematic therapy, including chemotherapy, targeted therapy or immune checkpoint inhibitor (ici); 4. no history of gastrectomy before systematic therapy. exclusion criteria: 1. incompletable clinical data; 2. siewert i type esophagus cancer.
feasibility of tracheobronchial reconstruction using bioengineered aortic matrices

Conditions: Trachea Diseases; Tracheal Stenosis; Lung Cancer; Tuberculosis; Tracheitis; Airway Disease

Summary: we used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.


Eligibility criteria:
inclusion criteria: * patients with advanced benign or malignant lesions involving trachea or bronchi, and has failed conventional treatment. * patients with proximal pulmonary tumors that require surgical resection and has involved proximal airways which is indicated for a pneumonectomy, sleeve lobectomy, or carina resection. exclusion criteria: * less than 20-year-old * unable to obtain informed consent. * pulmonary tumors that can be treated with standard lobectomy. * unresectable locally advanced malignant tumors * malignant tumors with contralateral lymph nodes involvement. * malignant tumors with distal metastases; except for simple resectable brain metastasis. * tracheal lesions which can be treated with standard resection and direct anastomosis. * allergic to iodine * unable to tolerate standard lobectomy * has human immunodeficiency virus infection * tracheal stenosis at proximal 2 cm on upper trachea

Keywords: tracheal reconstruction bronchial reconstruction cryopreserved aorta
catheter in the prevention of urinary tract infections and crystallization study(cputics)

Conditions: Urinary Catheter

Summary: this is a single-center randomized controlled trial in comparison of parylene-coated versus silicone catheters in the prevention of urinary tract infections and crystallization.

this study was a single-center randomized controlled trial, enrolling patients with indwelling urinary catheterization time greater than 2 weeks, and comparing the incidence of urinary tract infections in the two groups with different indwelling urinary catheter times by retaining mid-stream urine specimens for bacterial cultures on the 3rd, 7th, 10th, and 14th days after urinary catheter placement. and after removal of the urinary catheter,1-cm sections were taken from the head end and center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope. the incidence of urinary tract infections and crystal deposition on the inner wall of the catheter were compared between the patients in the matte catheter group (parylene-coated) and the patients in the glossy catheter group (plain silicone) during the period of catheterization, so as to evaluate the effectiveness of the two types of catheters in the clinical application.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years; 2. indwelling urinary catheter for ≥14 days; 3. fully understand the clinical trial protocol and sign the informed consent; exclusion criteria: 1. patients with confirmed urinary tract infection before indwelling urinary catheter; 2. those with renal dysfunction; 3. those who are allergic to silicone or silicone material; 4. those with low immunity susceptible to infection; 5. those who have participated in other clinical trials within 3 months; 6. others who are judged by the investigator to be unsuitable for clinical trials;

Keywords: urinary tract infections urinary tract crystallization